Job Opportunity: QA Specialist, CSV & Automation
We are currently seeking an experienced QA Specialist, CSV & Automation for our pharmaceutical client in Visp. This role supports large-scale CAPEX projects within a GMP-regulated manufacturing environment.
Job Description
The QA Specialist, CSV & Automation will be responsible for ensuring the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment, and utilities for GMP manufacturing of drug products as part of the Lonza CAPEX project portfolio in Stein, AG. Key responsibilities include:
- Ensuring that qualification/validation plans and the execution of equipment, infrastructure, and computerized systems adhere to Lonza Quality policies throughout all design phases.
- Approving SOPs, commissioning/qualification/validation protocols, and reports, as well as project-related CQV/CSV documents (e.g., URS, FAT/SAT, etc.).
- Providing QA leadership and support on qualification/validation topics related to ongoing projects, ensuring that selected vendors meet qualification standards.
- Acting as the first point of contact within GQE for lifecycle and compliance issues related to equipment, infrastructure, and computerized system qualification/validation, including documentation in shared global systems (e.g., Kneat, Trackwise, DMS, Unifier, etc.).
- Managing quality deviations, changes, and CAPAs/tasks proactively, taking leadership for their resolution while escalating when necessary.
Key Requirements
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- Significant experience in the GMP-regulated pharmaceutical industry, preferably in a Quality Unit role.
- Experience in a QA capacity for CSV/Automation of GMP systems related to aseptic fill-finish processes and facilities (including filling equipment, lyophilization, clean utilities, and clean room facilities).
- Fluent in English; proficiency in German is an advantage.
Only applications matching the job profile will be considered. Apply online using the form below.
Contact
For inquiries, please reach out to:
Alba Jansa
Email: alba.jansa@experis.ch
Phone: +41 61 282 22 13